Big Pharma is once again in hot water with the U.S. government for its overly aggressive — and possibly illegal — marketing of opioids.

The results of a Senate investigation released in early September detail how Arizona-based pharmaceutical company Insys Therapeutics consistently lied and misled insurance companies to increase sales of a painkiller containing the powerful synthetic opioid fentanyl. The report comes as the country continues to suffer from a years-long epidemic of opioid abuse.

The investigation, which was headed by Sen. Claire McCaskill (D-MO), found that Insys knowingly mislead insurance companies about the drug Subsys in order to get insurers to pay for it. In some of these cases, patients who didn’t need the drug and never should have been prescribed it were given access to Subsys and ended up dying.

“There is extensive evidence that Insys aggressively pressured its employees and the entire medical system to increase the use of a fentanyl product during a national epidemic that was taking the lives of tens of thousands of Americans a year in order to make more money,” Sen. McCaskill said in a statement.

Just a week before McCaskill’s report was released, Arizona Attorney General Mark Brnovich filed a suit for consumer fraud against Insys and three doctors in the state over false marketing to boost sales of Subsys.

“Their attempts to manipulate the prescription approval process for this drug appear to have been systemic, and anyone responsible for this manipulation deserves to be prosecuted,” said McCaskill.

Deceptive Practices

Subsys is a sublingual fentanyl spray that was approved by the Food and Drug Administration in 2012 to treat breakthrough pain in cancer patients. According to the report, insurance companies were only supposed to pay for the drug if a patient met three conditions: They had to have an active cancer diagnosis, were already being treated with an opioid, and Subsys would be used to treat any pain that could not be eliminated by the other opioid.

Insurance companies would only reimburse patients for the drug if they they met all three conditions, as the drug was extremely expensive, costing more than $20,000 a month. Given these strict requirements, Subsys was being approved for reimbursement by insurance companies in roughly just 30 percent of cases.

To get around this stringent criteria and increase the level of reimbursement, Insys launched a special division, known as the Insys Reimbursement Center (IRC). The report said that with promises of big bonuses for increasing Subsys sales, Insys employees would pretend to be working in doctor’s offices and use other deceptive practices with insurance representatives and pharmacy companies to ensure the drug was paid for.

“Insys techniques have included the falsification of medical histories for Subsys patients and the concealment of the company’s role in intervening with the insurers and pharmacy benefit managers,” said McCaskill.

The misleading marketing appears to have worked amazingly well for the pharmaceutical brand. In fact, between 2013 and 2016, Insys revenues tripled and the value of its stock increased by 296 percent. But at the same time, people who should never have been prescribed the medication were dying.

Boost Sales at Any Cost

One of the cases highlighted by McCaskill’s report involves a 32-year-old New Jersey woman named Sarah Fuller. Fuller suffered from chronic neck and back pain as the result of two car accidents, and she was prescribed Subsys by her doctor after first being given Percocet and Oxycontin.

According to an audio recording cited in the report, an Insys employee mislead representatives for a pharmacy benefit manager into believing she was employed by the doctor, and convinced the company that Fuller’s prescription should be approved for “breakthrough pain,” even though the Insys employee was aware Fuller didn’t have cancer. A little over a year later, Fuller died “due to an adverse reaction to prescription medications.”

The phone call cited in the report occurred during a period when Insys was pressuring its employees to increase insurance approvals of the drug. According to the report, Insys employees were given quotas and hefty financial incentives to raise the rate of Subsys authorizations.

Indeed, the investigation found internal company communications that outlined strategies for improving such authorizations, including one titled “Mitigate Prior Authorization Barriers.” These documents also laid out specific tasks to carry out this effort, such as launching a “1-800 reimbursement assistance hotline” and educating sales reps on the authorization process and its facilitation.

Another internal document discovered in the investigation found that IRC failed to establish “even basic measures” to ensure employees didn’t lie or mislead insurers into paying for Subsys prescriptions for patients who didn’t qualify for the medication. As a result, it’s alleged that Insys employees went so far as to falsify patients’ medical records in order to help them obtain the drug.

Addiction as a Business Model

What’s more, Insys management apparently knew this was happening. McCaskill’s report notes that a class-action lawsuit found that Insys management “was aware that only about 10 percent of prescriptions approved through the Prior Authorization Department were for cancer patients.”
Moreover, the report stated that an investigation by the Oregon Department of Justice found that “78 percent of preauthorization forms submitted by Insys on behalf of Oregon patients were for off-label uses.”

Perhaps the most pernicious example of the company’s operations was included in a letter McCaskill sent to Insys interim CEO Santosh Vetticaden in March 2017. In the letter, which requested various internal documents from the company, McCaskill noted the investigation shows “an industry apparently focused not on preventing abuse but on fostering addiction as a central component of its business model.”

The letter went on to quote one Insys sales rep who summed up his approach to patients as “Start them high and hope they don’t die.”

“It’s hard to imagine anything more despicable,” McCaskill said of the company’s sales tactics.